CLINICAL APPLICATION OF IPILIMUMAB IN PATIENTS WITH DISSEMINATED SKIN MELANOMA

Introduction: Application of ipilimumab (IPI) in the treatment of patients with disseminated melanoma, first demonstrated an increase in survival that was an important event in cancer immunotherapy. We present the results of treatment of patients within the framework of enhanced access to the drug (SA184-EAP).

Materials and methods: from September 2012 to August 2014 71 patients with metastatic melanoma, with signs of tumor progression, received earlier from 1 to 6 lines of drug therapy were enrolled in protocol of treatment in Petrov Oncology Institute. Median age of patients was 51 years (range from 21 to 76 years). In 39 (60%) of patients IV stage was diagnosed, 25% of patients had metastases to the brain, 28% - had liver metastases, 19% - had bone metastases. All patients received IPI 3 mg/kg once every 3 weeks for total 4 administration.

Results: A total there were 229 administrations of IPI in 71 patients (average number of administrations was 3.2). Thirty-nine patients (59%) had 4 administrations and 21 patients (35%) had 1-2 administrations. Most of the patients had at least one adverse event (AE) associated with the treatment. In 15 patients (21%) there were no adverse events. Three patients died due to adverse events possibly related to treatment: 1 – had kidney failure, 1 - had pulmonary embolism, 1 - had cerebral edema and the progression of cancer. Grade 3-4 adverse events were observed in 10 (14.1%) patients: grade 3 rash  - in 3 (4.2%) patients, grade 3 diarrhea - in 2 (2.8%) patients, grade 3 fatigue - in 2 (2 8%) patients, grade 3 dyspnea - in 1 (1.4%) patients, grade 4 of ALT and AST increasing - in 1 (1.4%) patient, grade 3 hypokalemia - in 1 (1.5%) patient. Efficacy of treatment was assessed in 54 patients, complete regression was detected in 3 (6%) patients, partial - in 6 (11%) patients. An objective response to treatment was observed in 28% of patients, the stabilization of process in 6 (11%) patients. Median follow-up was 144 days. The median time to progression was 81 days (95%; CI 73-105). The median overall survival was 411 days (95%; CI - 303-519).

Conclusion: Treatment with IPI satisfactorily tolerated by most patients and has significant clinical efficacy as the second and subsequent lines of drug therapy in patients with disseminated melanoma.

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